Positioning Duration and Pressure Injury Risk (PIP-ICU)

February 6, 2026 updated by: SEMA ŞAHİNER

The Effect of Positioning Duration on Pressure Injury Risk in Intensive Care Patients

This research aims to investigate the effect of positioning times on the risk of pressure injury in critically ill patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Pressure injuries, considered an indicator of quality of care, remain a significant concern today. They are a health problem that reduces the patient's quality of life, complicates the treatment process, and significantly increases costs. Immobility is one of the main risk factors for pressure injury development. In healthy individuals, discomfort occurs in an area subjected to pressure for a long enough period to cause ischemia, and the person changes their position via the afferent sensorimotor feedback system. Fewer than 20 movements per night significantly increase the risk of ulcer development. The factor causing ulcer formation is the inability of the individual to relieve the pressure applied to the tissue. Patients with limited mobility cannot change their body position on their own, and tissue perfusion is impaired in pressure-exposed areas, facilitating ulcer formation. Both the intensity and duration of pressure affect the effect. High pressure causes pressure to build up quickly, while the longer the pressure, the greater the risk of pressure buildup. In individuals at high risk of pressure injuries, frequent position changes are a primary policy for preventing pressure injuries. Experimental studies show that irreversible ischemia occurs when pressure is applied continuously for two hours or longer. The best method for reducing pressure in patients is repositioning. The literature indicates that while pressure injuries cannot be completely prevented, their incidence can be significantly reduced through evidence-based practices, particularly through assessment of at-risk patients, appropriate early nursing interventions, and preventive measures. Advances in the early detection of pressure injuries have been reported in the literature and primarily involve measuring inflammatory markers in anatomical regions to capture the first signs of tissue damage.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • - If the patient is conscious, they must volunteer to participate in the study.
  • For unconscious patients, a first-degree relative (mother, father, spouse, child) must agree to participate in the study.
  • The patient's dependency level score on the Barthel Activities of Daily Living Index must be 90 or below (moderately dependent, severely dependent, completely dependent).
  • The patient must not have developed a pressure injury.
  • The patient must be meeting their daily calorie needs as determined by the nutrition team.
  • There must be no contraindications to turning the patient to any side.
  • Patients who are at low risk according to the pressure injury scale (15 points or above according to the Braden Risk Assessment Scale).
  • The patient must not have an acute neurological problem.
  • Patients with a GCS score above 7.

Exclusion Criteria:

  • - If the patient is conscious, they do not consent to participate in the study.
  • For unconscious patients, their first-degree relative does not consent to participate in the study.
  • Patients with a Barthel Activities of Daily Living Index score above 90 (mildly dependent, fully independent).
  • The patient has an existing pressure injury.
  • The patient is not meeting their daily calorie needs as determined by the nutrition team.
  • There is a contraindication to turning the patient to any side.
  • Patients with moderate to high risk according to the pressure injury scale (score below 15 according to the Braden Risk Assessment Scale).
  • The patient has an acute neurological problem.
  • Patients with a GCS score of 7 or below.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: experimental group
Position changes will be implemented at 1-hour intervals.
Behavioral: Position Change - 1 Hour
Patient positions will be changed at 1-hour intervals.
Active Comparator: control group
Position changes will be implemented at 2-hour intervals.
Behavioral: Position Change - 2 Hours
Patient positions will be changed at 2-hour intervals.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Skin Integrity Changes
Time Frame: Recording body temperature by measuring it with a body temperature measurement device every 24 hours for 72 hours.
Evaluation of changes in body temperature as a risk factor for pressure injury.
Recording body temperature by measuring it with a body temperature measurement device every 24 hours for 72 hours.
Skin Integrity Changes
Time Frame: Body moisture will be assessed and documented every 24 hours over a 72-hour period using a body moisture measurement device.
Evaluation of changes in body moisture level as a risk factor for pressure injury
Body moisture will be assessed and documented every 24 hours over a 72-hour period using a body moisture measurement device.
Skin Integrity Changes
Time Frame: Whether changes in skin appearance, such as bruising, occur will be assessed and recorded through observation every 24 hours over a 72-hour period.
Assessment of the occurrence of changes in skin appearance, such as bruising, considered as risk factors for pressure injury.
Whether changes in skin appearance, such as bruising, occur will be assessed and recorded through observation every 24 hours over a 72-hour period.
Skin Integrity Changes
Time Frame: The presence of changes in skin appearance, such as edema, will be assessed and recorded through observation at 24-hour intervals over a 72-hour period.
Assessment of the occurrence of changes in skin appearance, such as edema, considered as risk factors for pressure injury.
The presence of changes in skin appearance, such as edema, will be assessed and recorded through observation at 24-hour intervals over a 72-hour period.
Skin Integrity Changes
Time Frame: The presence of changes in skin appearance, such as redness, will be assessed and recorded through observation at 24-hour intervals over a 72-hour period.
Assessment of the occurrence of changes in skin appearance, such as redness, considered as risk factors for pressure injury.
The presence of changes in skin appearance, such as redness, will be assessed and recorded through observation at 24-hour intervals over a 72-hour period.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Braden Risk Assessment Score
Time Frame: Evaluations will be conducted and documented at 24-hour intervals over a 72-hour period using the scale.
Pressure injury risk will be quantitatively assessed using the Braden Pressure Ulcer Risk Assessment Scale, which consists of six subdimensions: sensory perception, moisture, activity, mobility, nutrition, and friction/shear. Total scores range from 6 to 23, with decreasing scores over the assessment period indicating an increased risk of pressure ulcer development.
Evaluations will be conducted and documented at 24-hour intervals over a 72-hour period using the scale.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SEMA ŞAHİNER

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bartin State Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Esra ÖZKAN, Kemal TURHAN, The Effect of Position Time on the Formation of Pressure Ulcer in Bedridden Patients, Turkiye Klinikleri J Nurs Sci. 2019;11(3):246-54.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-SBB-0140

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

In this study, individual patient data was used in an anonymized form and will not be shared with third parties in accordance with the principles of patient privacy and the protection of personal data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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